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OTC Lubricating Eye Drops in Dry Eye Disease
NCT07676084Phase 4
Key facts
- Status
- Recruiting
- Start
- Jun 2026
- Primary completion
- Oct 2026
- Countries
- 1
- Sponsor
- Andover Eye Institute
- Conditions
- dry eye disease (DED)
01
Overview
Phase 4, randomised, single-blind trial of polyethylene glycol 400 in dry eye disease (DED) (5 arms), sponsored by Andover Eye Institute. Primary endpoint: Ocular Surface Disease Index at 14 days. Started Jun 2026; status: recruiting.
02
Design
5 arms- Study design
- RandomizedSingle-blind
Blink Triple Care (QID)
Preservative Free Polyethylene glycol 400 0.25% administered 4 times daily
Blink Triple Care (BID)
Preservative Free Polyethylene glycol 400 0.25% administered 2 times daily
Systane PRO (QID)
Propylene Glycol (0.6%) administered 4 times daily
Refresh Optive Mega-3 (QID)
Carboxymethylcellulose sodium 0.5%, Glycerin 1.0%, Polysorbate 80 0.5% administered 4 times daily
Systane Original (QID)
Propylene Glycol (0.6%) administered 4 times daily
03
Who it enrols
Adults with dry eye disease for at least 6 months and an OSDI score >13, excluding those with secondary DED, abnormal lid/corneal anatomy, active ocular infection/inflammation, recent ocular surgery, or recent use of prescription dry eye treatments or contact lenses.
04
Endpoints
Primary
Ocular Surface Disease Index
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